On October 30, 2020 the FDA published a list of essential medicines, medical countermeasures, and critical inputs as required by President Trump’s August 2020 Executive Order on Ensuring Essential Medicines, Medical Countermeasures, and Critical Inputs Are Made in the United States (Executive Order 13944), which required the U.S. government to purchase “essential” medicines and medical supplies produced domestically, rather than abroad. We previously wrote about this Executive Order in August (available here), expecting that once the list was issued, government agencies would begin implementing the “Buy American” priorities for these products and materials. The FDA has identified around 227 drugs and 96 devices, along with their respective critical inputs or active ingredients, that the FDA believes “are medically necessary to have available at all times” for the public health. Agencies across the federal government should now begin making non-competitive awards “to the maximum extent permitted by law,” for drugs and medical supplies on this list that are produced in the United States. We have yet to see how agencies will implement these requirements in regulations or class deviations, but publication of this list is an important first step in implementing the rest of the “Buy American” priorities in the Executive Order.
Continue Reading “Buy American” Update: FDA Issues List Of Essential Medicines Required By Executive Order

Immunity under the Public Readiness and Emergency Preparedness (“PREP”) Act is a moving target for government contractors and other companies manufacturing or distributing personal protective equipment (PPE) in the COVID-19 public health response. We wrote previously about new liability protections afforded to manufacturers and distributors of certain face masks approved by National Institute for Occupational Safety and Health (“NIOSH”) through the Families First Coronavirus Response Act, and the later expanded scope of that protection provided by the Coronavirus Aid, Relief, and Economic Security (“CARES”) Act and amended PREP Act declaration by Department of Health and Human Services. Until recently, the list of devices eligible for liability immunity seemed to be continuously growing as the COVID-19 public health response required more and more PPE. But last week, the Food and Drug Administration (“FDA”) took a significant step back, retracting its Emergency Use Authorization (“EUA”) for respirators from 75 manufacturers in China, which previously had been approved for use in the response to COVID-19. This retraction has the additional effect of disqualifying government contractors, and other companies that distribute newly unauthorized respirators, from PREP Act immunity in connection with these devices.
Continue Reading Not So Fast – FDA Retracts Authorization for Some Respirators Made in China

All respirators approved by the National Institute of Occupational Safety and Health (“NIOSH”) now are “covered countermeasures” under the Public Readiness and Emergency Preparedness (“PREP”) Act provisions of the Public Health Service Act, and their manufacturers and distributors are eligible for immunity from suits for injury and death resulting from use of the masks in the public health response to COVID-19. The Secretary for the Department of Health and Human Services (“HHS”) issued an updated PREP Act declaration implementing this addition to the covered countermeasures eligible for PREP Act immunity, with retroactive effect to March 27, 2020.
Continue Reading PREP Act Update: All NIOSH-Approved Respirators Now Are Covered Countermeasures Eligible for Immunity

The novel coronavirus (“COVID-19”) pandemic has given Department of Veterans Affairs (“VA”) contractors several powerful new tools in their toolbelts, and VA contractors should not leave available protections on the table. VA contractors, including those supplying medical devices under the MSPV-NG bridge contract and pharmaceuticals on a VA Federal Supply Schedule (“FSS”), now can negotiate for extraordinary limitations on liability (in addition to some provided by statute), among other opportunities. Particularly for contractors providing goods and services used in the COVID-19 pandemic response, it is crucial to understand both new protections available and other changes to the rules of VA contracting.
Continue Reading COVID-19 Changes Contracting at the VA

COVID-19 took the world by surprise and continues to spread across the globe in more than 210 countries and counting.  The outbreak in the United States escalated rapidly, with over 585,000 confirmed cases as of April 14, 2020.  The federal government and a number of hard-hit states were caught off guard, and soon learned that their inventories of personal protective equipment (“PPE”) and other life-saving equipment such as test kits and ventilators were insufficient to keep pace with the pandemic.  The demand for equipment to fight COVID-19 skyrocketed and government and commercial entities have shifted into high gear to respond.  Whether motivated by humanitarian concern or commercial enterprise, many state and local governments, companies and individuals are now looking abroad to procure critical supplies on an expedited basis.  At the same time, many foreign industrial manufacturers are positioning themselves for the high demand of exports by adapting their facilities to produce PPE.  For example, Chinese electric car maker BYD announced on March 13, 2020 it is now the largest face mask factory in the world—less than one month after converting its facilities in response to the pandemic.  In the midst of these exigent circumstances, the global supply chain landscape is replete with Foreign Corrupt Practices Act landmines—and well-intentioned companies hoping to partner with foreign PPE manufacturers could become a casualty if they don’t watch their step.
Continue Reading FCPA Landmines Beneath the Surface of the COVID-19 Crisis

As the Federal Government struggles to secure a sufficient volume of Personal Protective Equipment (“PPE”) – i.e., gloves, masks, gowns, face shields, etc. – for the nation’s health care workers and first responders, states and localities have begun taking it upon themselves to identify and protect the resources available within their geographic boundaries. These efforts have resulted in a growing number of state and local orders targeted at manufacturers, suppliers, and distributors of PPE and medical equipment.
Continue Reading Seize The Day (and the PPE) – An Overview of State and Local Rules Governing the Possession and/or Sale of Personal Protective Equipment (“PPE”) during the COVID-19 Public Health Emergency

There is more than $2 trillion on the line and the multi-trillion-dollar question is: Who’s minding the store?  On March 27, 2020, in response to the financial set-back created by the novel COVID-19 pandemic, President Trump signed into law the more than $2 trillion Coronavirus Aid, Relief, and Economic Security Act (the “CARES Act”) – by far the largest economic relief package in U.S. history.[1]  The CARES Act’s purpose is to keep the U.S. economy afloat and provide relief to struggling Americans, large corporate sectors, and small businesses while the nation battles this pandemic.  With $500 billion allocated for big corporations, $377 billion for small businesses, and another $153.5 billion for healthcare, these relief moneys (like with most government funds) are sure to come with strings attached in the form of complex regulations and substantial oversight, with enforcement not far behind.
Continue Reading The CARES Act – Who’s Minding the Store?

Last week the White House issued two additional Executive Orders (“EOs”) related to EO 13909, the subject of our March 20, 2020 blog post: Presidential Executive Order Calls on HHS to Issue Priority Contracts and Allocate Scarce Medical Resources.
Continue Reading Presidential Executive Orders Delegate Additional Authorities To Respond To COVID-19 Outbreak

COVID-19 (a.k.a. the Coronavirus) is upon us and it looks like it is here to stay, at least for the foreseeable future.  In January, the Department of Health and Human Services declared the Coronavirus outbreak to constitute a Public Health Emergency, and on March 13, 2020, President Trump declared it a National Emergency.  The President noted that the spread of the virus “threatens to strain our Nation’s healthcare systems.”  As medical needs surge coupled with increases in state and city shutdowns to combat and contain the virus, a drain on government resources is almost certain.  As such, in the wake of the Coronavirus outbreak, many companies are looking for ways to help, and some are willing to do so at no cost through free goods and services to the United States Government in hopes of alleviating such strain.  Many companies, however, fear that such gifts might be prohibited under federal gift rules and the Antideficiency Act (an Act originating in the 1880s that, in some cases, prevents the Government from accepting voluntary services). This article explores how companies can provide free goods and services to the Government within the strictures of applicable statutes and regulations.
Continue Reading Gifting Goods & Services to the U.S. Government in the Wake of the Coronavirus Outbreak

On March 18, 2020, the President signed into law the Families First Coronavirus Response Act, H.R. 6201, Pub. L. No. 116-127 (the “Coronavirus Response Act”). Among other measures in response to the current pandemic, this legislation offers manufacturers and distributors of industrial-grade face masks, referred to as “personal respiratory protective devices,” immunity from liability arising from use of the masks in connection with COVID-19. This immunity is retroactive to January 27, 2020, will last through October 1, 2024, and stems from the Federal Government’s effort to respond to the shortage of available masks. The law follows the Food & Drug Administration’s Emergency Use Authorization for emergency use of industrial-grade face masks in health care settings on March 2, 2020.
Continue Reading Families First Coronavirus Response Act: Face Mask Manufacturers and Distributors Protected from Liability for Coronavirus Deaths

Last week, we (Ryan and Jonathan) published the COVID-19 Federal Contractor’s Survival Guide in the Coalition For Government Procurement’s Friday Flash. The Guide was very well received – perhaps because it didn’t once instruct anyone to wash his/her hands – and several readers asked us to expand it to cover additional topics and new developments. Because the COVID-19 contracting landscape is changing so fast, we agreed an update made sense. To make the update as comprehensive as possible, we have retained the information from the original Survival Guide, and supplemented it with a wealth of new information, including answers to the questions asked during last week’s Coalition Survival Guide webinar, which is available for free download from the Coalition here.

Thus, without further ado, we offer you the COVID-19 Federal Contractor’s Survival Guide 2.0.
Continue Reading COVID-19 Federal Contractor’s Survival Guide 2.0